A device for managing a medication regime

ABSTRACT

A device for communicating a driving ability level of a user, the device comprising at least a processor, a memory and a wireless transceiver. The device is configured to: receive a communication from a medical device, wherein the communication comprises information relating to a condition of the medical device; and send a communication to a vehicle. The information relating to a condition of the medical device is processed in order to determine a driving ability level of the user by the assignment of a category selected from a group comprising a first category and a second category.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is the national stage entry of InternationalPatent Application No. PCT/EP2018/083847, filed on Dec. 6, 2018, andclaims priority to Application No. EP 17306738.0, filed on Dec. 11,2017, the disclosures of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to a device and system configured tomonitor the use of a medical device, such as an injection device, makean assessment of a user's impairment in relation to driving a vehicleand transmit information associated with the assessment.

BACKGROUND

A variety of diseases exists that require regular treatment by injectionof a medicament. Such injection can be performed by using injectiondevices, which are applied either by medical personnel or by patientsthemselves. As an example, type-1 and type-2 diabetes can be treated bypatients themselves by injection of insulin doses, for example once orseveral times per day. For instance, a pre-filled disposable insulin pencan be used as an injection device. Alternatively, a re-usable pen maybe used. A re-usable pen allows replacement of an empty medicamentcartridge by a new one. Either pen may come with a set of one-wayneedles that are replaced before each use. The insulin dose to beinjected can then for instance be manually selected at the insulin penby turning a dosage knob and observing the actual dose from a dosewindow or display of the insulin pen. The dose is then injected byinserting the needle into a suited skin portion and pressing the dosageknob or an injection button of the insulin pen.

Alternatives to a disposable injection pens include connectableinjection devices, such as drug pumps. For instance, insulin may bedelivered by a drug pump. Other medical devices include meters formonitoring the condition of a patient, such as blood glucose meters ormethods of indirectly measuring blood glucose levels, blood pressuremonitors, pulse monitors, etc. Intelligent electronic pill boxes may beused to monitor the delivery of non-injectable medicaments.

Patients may fail to administer the correct quantity of the medicament,or follow the correct dosage regime. This can result in impairment ofthe patient. For instance, diabetic patients who have not following thecorrect medicament regime may experience fatigue, blurred vision, and/orconfusion. Patients who require cardiovascular medicaments and patientswho require pain medicament can become similarly impaired.

SUMMARY

To be able to monitor insulin injection, for instance to prevent falsehandling of the insulin pen or to keep track of the doses alreadyapplied, it is desirable to measure information related to a conditionand/or use of the injection device, such as for instance information onthe injected insulin dose.

According to an aspect of the disclosure, there is provided a device forcommunicating a driving ability level of a user, the device comprisingat least a processor, a memory and a wireless transceiver, wherein thedevice is configured to: receive a communication from a medical device,wherein the communication comprises information relating to a conditionof the medical device; and send a communication to a vehicle; whereinthe information relating to a condition of the medical device isprocessed in order to determine a driving ability level of the user bythe assignment of a category selected from a group comprising a firstcategory and a second category.

The device may be configured to send the communication to the vehiclevia a smart key associated with the vehicle. Alternatively, the devicemay be a smart key associated with the vehicle and storing a medicalmonitoring application.

The smart key may be configured to allow a user to access a vehicleand/or activate a vehicle. The device may be a smartphone storing amedical monitoring application and an application for communication withthe vehicle.

According to another aspect of the disclosure, there is provided asystem comprising any device as disclosed herein, further comprising theelectronic warning system of the vehicle.

The electronic warning system may be configured to: if the drivingability level of the user is assigned to the first category, not emit awarning signal; and if the driving ability level of the user is assignedto the second category, emit a warning signal.

The driving ability level of the user may be assigned to a categoryselected from the group further comprising a third category, and whereinthe electronic warning system of the vehicle is further configured to:if the driving ability level of the user is assigned to the thirdcategory, prevent the starting of the engine of the vehicle or activatea safety assistant system.

The device may be configured to: if the driving ability level of theuser is assigned to the second category, send a communication to anavigation system.

The device may be configured to: store information relating to amedication dose history of the user; determine, based on the storedmedication dose history, a due time for a subsequent medication doseadministration; and wirelessly transmit data representing the due timefor the subsequent medication dose administration to a smart keyassociated with a vehicle or to an electronic warning system of avehicle.

The device may be further configured to wirelessly communicate with aninjection monitoring device and to receive dosing information from theinjection monitoring device, the dosing information comprising a date,time and data representing an administered medicament dose. The devicemay be further configured to update the stored medication dose historybased on the received dosing information.

The device may be further configured to determine a driving abilitylevel of the user by inferring the user's physiological condition basedon a comparison of the current time with the due time for the subsequentmedication dose administration.

The device may be a smartphone storing a medical monitoring application.There is provided a system comprising the aforementioned device and thesmart key associated with a vehicle, wherein the smart key is configuredto wirelessly transmit the data representing the due time for thesubsequent medication dose administration to an electronic warningsystem of the associated vehicle. The smart key may be furtherconfigured to wirelessly transmit an indication of a driving abilitylevel of the user to the electronic warning system of the associatedvehicle. The smart key may be further configured to perform aplausibility check in response to receiving the data representing thedue time for the subsequent medication dose administration, theplausibility check comprising confirming the received information withthe smartphone. The smart key may be further configured to: transmit anunlock signal to the associated vehicle; in response to transmitting theunlock signal to the associated vehicle, compare the current time withthe received data representing the due time for the subsequentmedication dose administration; and communicate the result of thecomparison to the electronic warning system of the associated vehicle.The smartphone and smart key may be part of a system which may furthercomprise the electronic warning system of the vehicle configured to:receive the result of the comparison of the current time with the duetime for the subsequent medication dose administration; and if thecurrent time is later than the due time, emit a warning signal. Theelectronic warning system of the vehicle may be further configured to:if the current time is later than the due time, prevent the starting ofthe engine of the vehicle.

Alternatively, the device may be a smart key associated with a vehicle,the smart key storing a medical monitoring application, and wherein thesmart key is configured to wirelessly transmit the data representing thedue time for the subsequent medication dose administration to anelectronic warning system of the associated vehicle. The smart key maybe further configured to wirelessly transmit an indication of a drivingability level of the user to the electronic warning system of theassociated vehicle. The smart key may be further configured to perform aplausibility check in response to receiving the data representing thedue time for the subsequent medication dose administration, theplausibility check comprising confirming the received information withthe injection monitoring device. The smart key may be further configuredto: transmit an unlock signal to the associated vehicle; in response totransmitting the unlock signal to the associated vehicle, compare thecurrent time with the received data representing the due time for thesubsequent medication dose administration; and communicate the result ofthe comparison to the electronic warning system of the associatedvehicle. The smart key may be part of a system which may furthercomprise an electronic warning system configured to: receive the resultof the comparison of the current time with the due time for thesubsequent medication dose administration; and if the current time islater than the due time, emit a warning signal. The system may comprisethe electronic warning system of the vehicle further configured to: ifthe current time is later than the due time, prevent the starting of theengine of the vehicle.

The aforementioned systems may further comprise a medical device. Thesystems may further comprise an injection monitoring device.

In an aspect, there is provided a system comprising any device asdisclosed herein, and the electronic warning system of a vehicle,wherein the device is configured to: receive a communication from amedical device, wherein the medical device is a permanent monitoringdevice and the communication comprises information relating to aphysiological condition of a user; wherein the information relating to aphysiological condition of the user is processed in order to determine adriving ability level of the user by the assignment of a categoryselected from a group comprising a first category, a second category,and a third category; wherein the electronic warning system of thevehicle is configured to: if the driving ability level of the user isassigned to the third category, prevent the starting of the engine ofthe vehicle or activate a safety assistant system.

The activation of a safety assistant system may cause the vehicle toslow and/or stop.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows an exploded view of an injection device;

FIG. 2 depicts a data collection device, attached to the injectiondevice of FIG. 1;

FIG. 3 is a schematic illustration of a system in which the presentdisclosure can be used;

FIG. 4 is a schematic illustration of a different system in which thepresent disclosure can be used;

FIG. 5 is a schematic illustration of a system in which the presentdisclosure can be used, showing an example of a system including acontinuous blood glucose meter, a smart key, and a vehicle;

FIG. 6 is a schematic illustration of a system in which the presentdisclosure can be used, showing an example of a system including: adevice such as a smart phone comprising an App, an intelligent medicaldevice or a supplementary device for such a medical device, remotestorage services, and a vehicle;

FIG. 7 is a schematic illustration of a system in which the presentdisclosure can be used, showing an example of a system including: adevice such as a smart phone comprising an App, an intelligent medicaldevice or a supplementary device for such a medical device, a smart key,remote storage services, and a vehicle;

FIG. 8 is a schematic illustration of a system in which the presentdisclosure can be used, showing an example of a system including: adevice such as a smart phone comprising an App, an intelligent medicaldevice or a supplementary device for such a medical device, and avehicle; and

FIG. 9 shows examples of standardized symbols from pharmaceuticalpackaging suitable for use with the disclosed systems.

DETAILED DESCRIPTION

In the following disclosure, embodiments will be described withreference to an insulin injection device. The present disclosure ishowever not limited to such application and may equally well be deployedwith injection devices that eject other medicaments, or with any otherkind of medical device, including drug pumps, meters for monitoring thecondition of a patient, blood glucose meters, meters for indirectlymeasuring blood glucose level, blood pressure monitors, pulse monitors,intelligent electronic pill boxes, and the like.

Where a medical device is referred to this may refer to the medicaldevice itself, or may refer to a supplementary device designed to attachto a medical device and to derive information from the medical device.

Where a condition of a medical device is referred to, this may refer toany condition referred to herein. The condition of the medical deviceincludes but is not limited to: a date and time of medicament delivery,a quantity of medicament delivery, the type of medicament delivered, theidentity of the medicament batch, the medicament expiry date, and anycombination thereof. The condition of the medical device may alsoinclude but is not limited to: the information gathered or determined bythe medical device, for instance blood glucose levels, blood pressure,pulse rate, or any combination thereof.

A smart key may be a device configured to allow a user to access avehicle and/or activate a vehicle. Activating a vehicle may includestarting an engine and/or activating the ignition.

FIG. 1 is an exploded view of an injection device 1, which may forinstance represent Sanofi's Solostar® insulin injection pen or Sanofi'sAllStar® insulin injection pen, however the present disclosure is alsocompatible with other types and makes of injection pens as describedbelow.

The injection device 1 of FIG. 1 is a pre-filled, disposable injectionpen that comprises a housing 10 and contains an insulin container 14, towhich a needle 15 can be affixed. The needle is protected by an innerneedle cap 16 and an outer needle cap 17, which in turn can be coveredby a cap 18. An insulin dose to be ejected from injection device 1 canbe selected by turning the dosage knob 12, and the selected dose is thendisplayed via dosage window 13, for instance in multiples of so-calledInternational Units (IU), wherein one IU is the biological equivalent ofabout 45.5 micrograms of pure crystalline insulin (1/22 mg). An exampleof a selected dose displayed in dosage window 13 may for instance be 30IUs, as shown in FIG. 1. It should be noted that the selected dose mayequally well be displayed differently. A label (not shown) is providedon the housing 10. The label includes information about the medicamentincluded within the injection device, including information identifyingthe medicament. The information identifying the medicament may be in theform of text. The information identifying the medicament may also be inthe form of a color. The information identifying the medicament may alsobe encoded into a barcode, QR code or the like. The informationidentifying the medicament may also be in the form of a black and whitepattern, a color pattern or shading.

The dosage window 13 may be in the form of an aperture in the housing10, which permits a user to view a limited portion of a number sleeve 70that is configured to move when the dosage knob 12 is turned, to providea visual indication of a currently programmed dose. Alternatively, thenumber sleeve 70 may remain stationary during the dose dialing phase,and the dosage window 13 may move as a dose is dialed in to reveal thenumber corresponding to the dialed dose. In either case, the numbersleeve 70 may be a component which rotates when a dose is beingdispensed from the injection device 1.

The injection device 1 may be configured so that turning the dosage knob12 causes a mechanical click sound to provide acoustical feedback to auser. The number sleeve 70 mechanically interacts with a piston ininsulin container 14. When needle 15 is stuck into a skin portion of apatient, and then injection button 11 is pushed, the insulin dosedisplayed in display window 13 will be ejected from injection device 1.When the needle 15 of injection device 1 remains for a certain time inthe skin portion after the injection button 11 is pushed, a highpercentage of the dose is actually injected into the patient's body.Ejection of the insulin dose may also cause a mechanical click sound,which is however different from the sounds produced when using dosageknob 12. In some other embodiments, the injection device 1 does not havea separate injection button 11 and a user depresses the entire dosageknob 12, which moves longitudinally relative to the housing 10, in orderto cause the medicament to be dispensed.

In the various embodiments, during delivery of the insulin dose, thedosage knob 12 is turned to its initial position in an axial movement,that is to say without rotation, while the number sleeve 70 is rotatedto return to its initial position, e.g. to display a dose of zero units.

Injection device 1 may be used for several injection processes untileither insulin container 14 is empty or the expiration date of injectiondevice 1 (e.g. 28 days after the first use) is reached.

Furthermore, before using injection device 1 for the first time, it maybe necessary to perform a so-called “prime shot” to remove air frominsulin container 14 and needle 15, for instance by selecting two unitsof insulin and pressing injection button 11 while holding injectiondevice 1 with the needle 15 upwards. For simplicity of presentation, inthe following, it will be exemplarily assumed that the ejected dosessubstantially correspond to the injected doses, so that, for instancewhen making a proposal for a dose to be injected next, this dose equalsthe dose that has to ejected by the injection device. Nevertheless,differences (e.g. losses) between the ejected doses and the injecteddoses may of course be taken into account.

FIG. 2 shows an injection monitoring device 2 (also referred to as anadd-on device, supplementary device or dosage monitoring device herein)according to some embodiments. The injection monitoring device 2 isconfigured to be releasably secured to the injection device 1 and isshown attached to the injection device 1 in FIG. 2. FIG. 2 illustratessome of the major internal and external components of the injectionmonitoring device 2. Externally, the injection monitoring device 2comprises a display unit 4, a user input 6, and a battery compartment102.

Internally, the injection monitoring device 2 comprises electronics 24.The electronics 24 comprise at least a processor 25 and memory. Theelectronics 24 may comprise both a program memory and a main memory. Theprocessor 25 may for instance be a microprocessor, a Digital SignalProcessor (DSP), Application Specific Integrated Circuit (ASIC), FieldProgrammable Gate Array (FPGA) or the like. The processor 25 executesprogram code (e.g. software or firmware) stored in the program memory,and uses a main memory, for instance to store intermediate results. Themain memory may also be used to store a logbook on performedejections/injections. The program memory may for instance be a Read-OnlyMemory (ROM), and the main memory may for instance be a Random AccessMemory (RAM).

The injection monitoring device 2 also comprises a wireless unit 28,which is configured to transmit and/or receive information to/fromanother device in a wireless fashion. Such transmission may for instancebe based on radio transmission or optical transmission. In someembodiments, the wireless unit 28 is a Bluetooth transceiver.Alternatively, wireless unit 28 may be substituted or complemented by awired unit configured to transmit and/or receive information to/fromanother device in a wire-bound fashion, for instance via a cable orfiber connection. When data is transmitted, the units of the data(values) transferred may be explicitly or implicitly defined. Forinstance, in case of an insulin dose, always International Units (IU)may be used, or otherwise, the used unit may be transferred explicitly,for instance in coded form. The transmitted data also includes a timestamp associated with an injection. The injection monitoring device 2may also calculate, store and transmit other data relating to the user'smedicament regime and resulting physiological condition.

The injection monitoring device 2 also comprises an audio module 104configured to provide audio feedback to a user of the injectionmonitoring device 2. Both the wireless unit 28 and audio module 104 maybe coupled to and controlled by the electronics 24.

The injection monitoring device 2 may also comprise an optical sensor 26for reading information identifying the medicament. The informationidentifying the medicament may be the color of the housing 10 of theinjection device, or the color of an area of the housing or a labelaffixed to the housing. In these embodiments, the optical sensor 26 maybe a simple photometer configured to detect the color. In some otherembodiments, the information identifying the medicament may be a QRcode, or other similar encoded information and the optical sensor 26 maybe a camera or QR code reader. Further, one or more light sources may beprovided to improve reading of optical sensor 26. The light source mayprovide light of a certain wavelength or spectrum to improve colordetection by optical sensor 26. The light source may be arranged in sucha way that unwanted reflections, for example due to the curvature of thehousing 10, are avoided or reduced. In an example embodiment, theoptical sensor 26 is a camera unit configured to detect a code (forinstance a bar code, which may for instance be a one- or two-dimensionalbar code) related to the injection device and/or the medicamentcontained therein. This code may for instance be located on the housing10 or on a medicament container contained in injection device 1, to namebut a few examples. This code may for instance indicate a type of theinjection device and/or the medicament, and/or further properties (forinstance an expiration date). This code may be a QR code. The QR code isin general black and white and thus no color detection is required onthe part of the optical sensor 26. This allows the optical sensor 26 tobe simple and cheap to manufacture.

The processor 25 may be configured to check the information read by theoptical sensor 26 against pre-stored information in order to verify thatthe user is injecting the correct medicament. If the processor 25 doesnot recognize the information or recognizes the information asindicating a different medicament to that which the user should bereceiving at that time, then the injection monitoring device 2 mayproduce an alarm signal. The alarm signal may comprise words or graphicsdisplayed on the display unit 6 or sound produced by the audio module104. Alternatively, or in addition, the injection monitoring device 2may send an alarm signal to an external device via wireless unit 28.

The injection monitoring device 2 comprises an injection device statussensor 110 (also referred to herein as a non-contact sensor or firstnon-contact sensor). The status sensor 110 may take a number of forms.The status sensor 110 is configured to output signals indicative of thepositions of one or more components within the injection device 1. Thestatus sensor 110 may be referred to as a non-contact sensor, since itis able to sense the absolute position and/or movement of componentswithin the injection device 1 without contact between the sensor 110 andany of the components sensed. The electronics 24 receive these signalsand infer an operational state of the injection device 1 and causeinformation regarding the timing of the operation of the injectiondevice 1 to be recorded in the main memory and/or transmitted to anexternal device via the wireless unit 28.

The exact position of the status sensor 110 within the injectionmonitoring device 2 depends upon the position and movement range of themoveable component of the injection device being measured. The moveablecomponent may be close to the cylindrical part of the housing 10 of theinjection device 1. Therefore, the status sensor 110 is positionedadjacent the cylindrical part of the housing 10.

The status sensor 110 may be an optical sensor configured to observe thenumber sleeve 70 through the window 13 and thereby to read the dosedialed into the injection device 1. Alternatively, the status sensor 110may be an infrared sensor and the injection monitoring device 2 maycomprise a separate infrared light source. The status sensor 110 maythen observe the movement of components within the injection device 1through an area of the housing 10, dosage knob 12 or injection button 11which is opaque to visible light and infer the dialed or delivered doseof medicament from the observed movements. In some alternativeembodiments, the status sensor 110 may use another non-contact sensingtechnology, such as capacitive displacement sensing, magnetic inductionsensing or Eddy current sensing in order to measure the movement of theinternal components of the injection device 1.

In any case, the injection monitoring device 2 measures the amount ofmedicament injected from the injection device 1 and records the dosehistory. In some embodiments, the injection monitoring device 2 isfurther configured to use the determined dose history and other storedinformation about the user of the injection device 1 to determine thedue time and date for the user's next dose and/or the amount of theuser's next dose.

FIGS. 3 and 4 illustrate schematically two different systems in whichthe present disclosure can be used.

Referring firstly to FIG. 3, a system 200 is shown in which theinjection monitoring device 2 communicates wirelessly with a device 300for managing a medication regime of a user. The device 300 may forexample be a smartphone storing a medical monitoring application. Themedical monitoring application may be programmed to receive dosinginformation from the injection monitoring device 2, the dosinginformation comprising at least a date and time of the most recentinjection and data representing the administered medicament dose. Theinjection device 2 may be configured to transmit the dosing informationto the device 300 whenever a new injection is performed, oralternatively only in response to a user input.

The system 200 also comprises a smart key 400. The smart key 400 isconfigured to communicate wirelessly with the device 300. The smart key400 is also configured to at least partially control and to communicatewirelessly with an associated vehicle 500. The vehicle 500 may comprisea number of electronic systems, for example related to locking/unlockingthe vehicle and starting/stopping the vehicle. The vehicle 500 may alsocomprise an electronic warning system, configured to emit alerts undercircumstances, or even to prevent the engine of the vehicle from beingstarted.

Use of a smart key 400 as an interface between an external device and avehicle 500 can increase the safety of the system. This is because atthe point-of-delivery to the user the smart key 400 is already specificfor the user's vehicle 500, and hence it is easier to include securitysystems to avoid, for instance, hacking. This may be important, as thevehicle 500 can include safety assistant systems described herein, whichare capable of directly affecting the vehicle 500, for instance changingthe vehicle's speed.

A second advantage is that users do not always connect third partydevices, such as smartphones, to their vehicle. By including the smartkey 400 within the system, it is possible to configure the system sothat the user is forced to activate and/or connect the necessarydevices.

The medical monitoring application on the device 300 stores and managesthe user dose history. The medical monitoring application is configuredto use the stored dose history to determine a due date and time for theuser's next medication dose and/or dose volume/units. The medicalmonitoring application may also infer a physiological condition of theuser by comparing the current time with the determined due time for thenext medication dose. For example, where the user's medicament isinsulin used to treat diabetes, if the medical monitoring applicationdetermines that the current time is later than the due time for the nextdose, it may be inferred that the user's blood glucose levels are low.If the medical monitoring application determines that the current timeis much later than the due time, for example later than a predeterminedthreshold, then it may be inferred that the user has hypoglycemia. Theuser's physiological condition may be expressed in terms of theirfitness to drive a vehicle. This may also be referred to as a “wellnessparameter” which may define the likely level of the user's impairment.

The medical monitoring application can control the device 300 to presentinformation to the user, including the due date and time for their nextmedication dose administration and any warnings should the current timebe later than the determined due date and time. The medical monitoringapplication may also be programmed to control the device 300 to transmitat least the determined due date and time for the user's next medicationdose to the smart key 400. In some embodiments, the device 300 may alsotransmit an indication of the user's physiological condition and/orfitness to drive a vehicle.

The smart key 400 receives and stores the due time for the user's nextmedication dose administration. Whenever the smart key 400 is in rangeof the vehicle 500, or alternatively whenever the smart key 400 is usedto unlock the vehicle 500, the smart key communicates the due time tothe electronic warning system of the vehicle 500. If the user's nextdose is overdue (i.e. if the current time is later than the due time),the electronic warning system is configured to emit a warning. Thiswarning may take a number of forms, for example an audible alarm, whichmay be a spoken communication, or a visual indication. The vehicle 500may be provided with an internal display screen which may displaywarning text such as “Your next insulin dose is overdue and your abilityto drive may be impaired”. Additional traffic symbols or thestandardized symbols from pharmaceutical packaging can also be used(FIG. 9).

In addition the display screen may specify when the user's next dose wasdue. The display screen may also indicate the severity of the user'spotential impairment, for example using a scale of 1 to 3 and colorcoding, such as yellow, orange and red. In some embodiments, theelectronic warning system only emits a warning when the vehicle isactually started, or it may emit a different warning when the vehicle isstarted, for example an audible warning.

The vehicle 500 may provide the user with advice, and this advice may beprovided visually or audibly. For instance the internal display screenmay advise a user who is inferred to be impaired based upon their dosehistory to take action to alleviate their condition. This advice caninclude instructions or a reminder to take a dose of medicament or totake any recommended steps.

The vehicle 500 may include a navigation system. When the navigationsystem is in use for navigation the system may calculate, based upon thedue date and time for the next medication dose administration, a routethat incorporates an appropriate stop allowing the user to administertheir dose. The stop should be timed such that the user's fitness todrive is not impaired before the injection. The navigation system can beconfigured such that the stop is communicated to the user and the useris informed that a medicament dose should be administered. If thenavigation system is not in use for navigation, the system may indicate,based upon the due date and time for the next medication doseadministration, reminders of when the next medicament dose should beadministered and may indicate appropriate possibilities for the user tostop, for instance a rest area.

It is also possible for the navigation system to be comprised by device300, or comprised by a separate navigation device. In this case thenavigation system can be configured as described above, and thenecessary information is either already received by the device 300 orcommunicated to the separate navigation device. This communication maybe sent from the device 300, the smart key 400, or the vehicle 500.

FIG. 4 illustrates schematically a different system 250. In this system250, the injection monitoring device 2 communicates directly with thesmart key 400. In these embodiments the smart key 400 is programmed withthe medical monitoring application described above. The smart key 400may therefore receive dosing information from the injection monitoringdevice 2 directly, the dosing information comprising at least a date andtime of the most recent injection and data representing the administeredmedicament dose. The injection device 2 may be configured to transmitthe dosing information to the smart key 400 whenever a new injection isperformed, or alternatively only in response to a user input.

The smart key 400 may therefore use the medical monitoring applicationto store and manage the user dose history. The medical monitoringapplication is configured to use the stored dose history to determine adue time for the user's next medication dose. The smart key 400 mayperform a plausibility check on the received data by communicating withthe injection monitoring device 2 to confirm the accuracy of theinformation stored. The medical monitoring application may also infer aphysiological condition of the user by comparing the current time withthe determined due time for the next medication dose, as previouslydescribed. The user's physiological condition may be expressed in termsof their fitness to drive a vehicle.

The smart key 400 then communicates some or all of this informationdirectly to the vehicle 500. For example, the smart key 400 maydetermine a fitness of the user to drive, and communicate only thisinformation to the vehicle 500. Alternatively, the smart key 400 maycommunicate the due time for the user's next medicament dose to thevehicle and the electronic warning system of the vehicle may perform thecomparison. The smart key 400 may also have a small display screen. Thisscreen can be used to present information to the user, including the duetime for their next medication dose administration and any warningsshould the current time be later than the determined due time. Wheneverthe smart key 400 is in range of the vehicle 500, or alternativelywhenever the smart key 400 is used to unlock the vehicle 500, the smartkey communicates the fitness of the user to drive and/or the due time tothe electronic warning system of the vehicle 500. The electronic warningsystem of the vehicle 500 may then behave as described above withreference to FIG. 3.

The smart key 400 may continue to check the plausibility of the storeddata after the vehicle 500 is started, i.e. during driving. If duringdriving, the time for the user's next medicament dose becomes due, thenthe electronic warning system of the vehicle 500 may notify the driver.

FIG. 5 illustrates schematically a different system 260. In this system260, the medical device is a permanent monitoring device 261 that iscapable of continuously or regularly monitoring a condition, such as aphysiological condition, of a user. For instance, the permanentmonitoring device 261 may be a device that detects blood glucose levelseither directly or indirectly. Alternatively, the permanent monitoringdevice 261 may be a device that monitors the user's blood pressureand/or pulse.

At least a part of the information gathered by the permanent monitoringdevice 261, for instance including the user's condition or physiologicalcondition, may then be communicated directly with the smart key 400. Inthese embodiments the smart key 400 is programmed with the medicalmonitoring application described above. The smart key 400 may thereforereceive information, such as blood glucose levels, from the permanentmonitoring device 261 directly. The permanent monitoring device 261 maybe configured to transmit the information to the smart key 400 whenevera new measurement is performed, or whenever a deviation from a previouscondition is detected.

The smart key 400 may use the medical monitoring application to storeand manage a history of the user's condition. The medical monitoringapplication may be configured to use the stored history to determine aninference of a user's fitness to drive a vehicle. The medical monitoringapplication may be configured to use the stored history to determine adue time for the user's next medication dose; for instance, bloodglucose levels may allow the medical monitoring application to determinewhen the next insulin dose should be delivered.

The smart key 400 then communicates some or all of this informationdirectly to the vehicle 500. For example, the smart key 400 maydetermine an inference of the fitness of the user to drive, andcommunicate only this information to the vehicle 500. Alternatively, thesmart key 400 may communicate the user's physiological condition, or theestimated due time for the next dose, to the vehicle and the electronicwarning system of the vehicle may perform the comparison. The smart key400 may also have a small display screen. This screen can be used topresent information to the user, including their physiologicalcondition, the estimated time for the next dose, their fitness to drive,and any warnings should they be unfit to drive. Whenever the smart key400 is in range of the vehicle 500, or alternatively whenever the smartkey 400 is used to unlock the vehicle 500, the smart key may communicatethe fitness of the user to drive and/or the user's condition to theelectronic warning system of the vehicle 500. The electronic warningsystem of the vehicle 500 may then behave as described above withreference to FIG. 3. For instance, the user may be provided with awarning relating to their impairment to drive or may be provided withadvice relating to alleviating their condition. The advice may includereminders in relation to medicament doses or any other recommendedsteps.

The smart key 400 may communicate the user's condition to the vehicle500 after the vehicle 500 is started, i.e. during driving. If duringdriving, the user's condition changes or if the user is determined to beunfit to drive, then the electronic warning system of the vehicle 500may notify the driver and/or provide with advice relating to alleviatingthe user's condition. The vehicle 500 may be configured to reduce speedslowly and/or stop based on the received information or receivedinstructions from the smart key 400 and/or medical device. For instance,the vehicle 500 can comprise safety assistant systems such as a laneassistant, to control the directional stability using a camera, and aspeed assistant to control the vehicle speed. The safety assistantsystems may be controlled based upon the information or instructionsreceived from the smart key 400 and/or medical device. The vehicle 500may be able to activate hazard lights, headlights (dipped or high beam),and/or activate any audible warning such as a vehicle horn based uponthe information or instructions received.

The smart key 400 may be able to initiate an emergency call, forinstance the smart key 400 may be able to communicate with an externalcommunication device either directly or via the vehicle 500. Wherecommunication is via the vehicle 500, this may utilize the vehicle'sexisting connection to a mobile communication device, such as a“hands-free” system. Where an emergency call has been initiated, thesmart key 400 may be able to communicate relevant information, such asthe condition of the user, the user's name, the medical disorder fromwhich the user suffers, the type of medicament used by the user, thedose history, the history of the user's physiological condition, and anycombination thereof.

In an illustrative example, a user who suffers from diabetes may befitted with a connectable blood glucose monitoring (BGM) device. The BGMdevice communicates with a medical monitoring application which has beeninstalled upon a smart key, and the communication comprises the user'sblood glucose level. The medical monitoring application receives thisinformation and performs a comparison in order to determine if the useris, for instance, hypoglycemic. If the medical monitoring applicationinfers that the physiological condition of the user renders them unfitto drive, a communication will be sent to a vehicle. The communicationcomprises instructions to display a warning to the user. In addition,the vehicle may display advice to the user via the internal displayscreen, in this case the advice may include the advice to consume foodor drink likely to alleviate the user's condition, including food ordrink comprising sugar, fruit, chocolate, orange juice, or the like. Ifthe vehicle is stationary and the user's condition is of apre-determined level of severity the medical monitoring applicationsends instructions to the vehicle so that the engine is not allowed tostart. If the vehicle is in motion and the user's condition is of apre-determined level of severity, the medical monitoring applicationsends a communication to the vehicle to cause the safety assistantsystems of the vehicle to slowly bring the vehicle to a stationarypositon, to start the hazard lights, to sound the vehicle horn, and toinitiate an emergency telephone call including the condition of theuser, the user's blood glucose level, the user's name, the type ofinsulin used by the user, and last dose of insulin received.

In another illustrative example, a user taking painkillers, for instancea COX-2 inhibitor, may be monitored by medical devices such as a bloodpressure gauge and/or a pulse meter. These medical devices communicatewith a medical monitoring application which has been installed upon asmart key, and the communication comprises the user's physiologicalcondition. Based on the physiological condition the medical monitoringapplication may perform any action described above.

FIG. 6 illustrates schematically a different system 270. In this system270, the medical device 2 communicates wirelessly with a device 271. Thedevice 271 may for example be a smartphone storing a medical monitoringapplication described above and also storing an application that enablescommunication with a vehicle.

The medical monitoring application may be programmed to receiveinformation from the medical device 2. The information may includedosing information comprising at least a date and time of the mostrecent injection and data representing the administered medicament dose,and/or may include information comprising the user's condition orphysiological condition. The medical device 2 may be configured totransmit the information to the device 271 whenever a new injection ormeasurement is performed, when a deviation from a previous condition isdetected, or alternatively only in response to a user input.

The device 271 may communicate the information to remote storage 272.For instance, the remote storage 272 may be a cloud storage service. Theremote storage 272 may be used to store and manage a history of theuser's condition and dose history. The device 271 may be able to accessthe remote storage 272 in order to receive previous informationincluding the time and date of any medicament doses, the type ofmedicament, the medicament dose quantity, or any recorded physiologicalconditions. The device 271 may also be able to access the remote storage272 in order to receive the calculated or defined due time for theuser's next medicament dose. The device 271 may be able to access theremote storage 272 in order to receive data indicating an inferredphysiological condition of the user by comparing the current time withthe determined due time for the next medication dose, as previouslydescribed. The device 271 may be able to access the remote storage 272in order to receive data indicating the user's fitness to drive avehicle.

The device 271 then communicates some or all of this informationdirectly to the vehicle 500. For example, the device 271 may communicatea fitness of the user to drive to the vehicle 500. Alternatively, thedevice 271 may communicate the due time for the user's next medicamentdose to the vehicle and the electronic warning system of the vehicle mayperform the comparison. The vehicle 500 may then behave as describedabove with reference to FIG. 3, 4, or 5.

The device 271 may also have a display screen which can be used topresent information to the user, including the due time for their nextmedication dose administration and any warnings should the current timebe later than the determined due time.

FIG. 7 illustrates schematically a different system 280. In this system280, the medical device 2 communicates wirelessly with a device 281. Thedevice 281 is able to communicate with both a smart key 400 and remotestorage 272, which may be a cloud storage service.

In some aspects, the system 280 operates similarly to that described inrelation to FIG. 3. However, device 281 may communicate the informationreceived from the medical device 2 to the remote storage 272. The remotestorage 272 may be used to store and manage a history of the user'scondition and dose history. The device 281 may be able to access andcommunicate with the remote storage 272 in the manner described for FIG.6.

FIG. 8 illustrates schematically a different system 290. In this system290, the medical device 2 communicates wirelessly with a device 291. Thecommunication between the medical device 2 and the device 291 is thesame as described in relation to FIG. 3 above. The content of theinformation communicated to the vehicle 500, and the vehicle'scorresponding actions, are also the same as described in relation toFIG. 3 above. However, device 291 is able to directly communicate withvehicle 500, and may comprise an application for communication withvehicle 500. This communication may be a wireless or wiredcommunication, optionally this communication is via Bluetooth. Thiscommunication may, for instance, be via an existing mechanism forpairing a smart phone with an entertainment system of a vehicle.

For the systems described above, once the user's fitness to drive hasbeen inferred, the information may be categorized under “driving abilitylevel” categories. These categories may vary by severity, for instance afirst category may be assigned to users who are fit to drive. A secondcategory may be assigned to users who may be suffering from mildimpairment. A third category may be assigned to users who are sufferingfrom severe impairment. Further categories are envisaged indicatingvarying severity. The device or smart key may be configured to senddifferent instructions depending on the category to which the user'sdriving ability level has been assigned. The vehicle may be configuredto perform different actions depending on the category to which theuser's driving ability level has been assigned. For instance, thevehicle may emit warnings to user's in the second category, whereas mayprevent users in the third category from driving or activate safetyassistant systems as described above.

Examples above relating to diabetic patients who require insulin areillustrative. The present disclosure is also applicable to any users whomay become impaired. For instance, patients who require cardiovascularmedication or patients who require painkillers, such as a COX-2inhibitor.

While some examples of the injection monitoring device 2 are shownherein, the systems described above can be configured to work with anydevice configured to monitor the amount or dosages of medicamentadministered to a patient. For example, the above systems canaccommodate injection devices having integrated injection monitoringsolutions (e.g., injection devices which include an integrated dosemonitoring solution carried on-board the injection device) as well asother types of injection monitoring devices meant to be retrofitted oradded-on to existing injection devices (e.g., add-on injectionmonitoring devices which fit over and/or partially or completelyencapsulate the injection button 11 of the injection device 1). Thesystems described above can also accommodate one-time use or disposableinjection devices that include their own integrated injection monitoringdevices.

The terms “drug” or “medicament” are used synonymously herein anddescribe a pharmaceutical formulation containing one or more activepharmaceutical ingredients or pharmaceutically acceptable salts orsolvates thereof, and optionally a pharmaceutically acceptable carrier.An active pharmaceutical ingredient (“API”), in the broadest terms, is achemical structure that has a biological effect on humans or animals. Inpharmacology, a drug or medicament is used in the treatment, cure,prevention, or diagnosis of disease or used to otherwise enhancephysical or mental well-being. A drug or medicament may be used for alimited duration, or on a regular basis for chronic disorders.

As described below, a drug or medicament can include at least one API,or combinations thereof, in various types of formulations, for thetreatment of one or more diseases. Examples of API may include smallmolecules having a molecular weight of 500 Da or less; polypeptides,peptides and proteins (e.g., hormones, growth factors, antibodies,antibody fragments, and enzymes); carbohydrates and polysaccharides; andnucleic acids, double or single stranded DNA (including naked and cDNA),RNA, antisense nucleic acids such as antisense DNA and RNA, smallinterfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleicacids may be incorporated into molecular delivery systems such asvectors, plasmids, or liposomes. Mixtures of one or more drugs are alsocontemplated.

The drug or medicament may be contained in a primary package or “drugcontainer” adapted for use with a drug delivery device. The drugcontainer may be, e.g., a cartridge, syringe, reservoir, or other solidor flexible vessel configured to provide a suitable chamber for storage(e.g., short-or long-term storage) of one or more drugs. For example, insome instances, the chamber may be designed to store a drug for at leastone day (e.g., 1 to at least 30 days). In some instances, the chambermay be designed to store a drug for about 1 month to about 2 years.Storage may occur at room temperature (e.g., about 20° C.), orrefrigerated temperatures (e.g., from about −4° C. to about 4° C.). Insome instances, the drug container may be or may include a dual-chambercartridge configured to store two or more components of thepharmaceutical formulation to-be-administered (e.g., an API and adiluent, or two different drugs) separately, one in each chamber. Insuch instances, the two chambers of the dual-chamber cartridge may beconfigured to allow mixing between the two or more components prior toand/or during dispensing into the human or animal body. For example, thetwo chambers may be configured such that they are in fluid communicationwith each other (e.g., by way of a conduit between the two chambers) andallow mixing of the two components when desired by a user prior todispensing. Alternatively or in addition, the two chambers may beconfigured to allow mixing as the components are being dispensed intothe human or animal body.

The drugs or medicaments contained in the drug delivery devices asdescribed herein can be used for the treatment and/or prophylaxis ofmany different types of medical disorders. Examples of disordersinclude, e.g., diabetes mellitus or complications associated withdiabetes mellitus such as diabetic retinopathy, thromboembolismdisorders such as deep vein or pulmonary thromboembolism. Furtherexamples of disorders are acute coronary syndrome (ACS), angina,myocardial infarction, cancer, macular degeneration, inflammation, hayfever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs anddrugs are those as described in handbooks such as Rote Liste 2014, forexample, without limitation, main groups 12 (anti-diabetic drugs) or 86(oncology drugs), and Merck Index, 15th edition.

Examples of APIs for the treatment and/or prophylaxis of type 1 or type2 diabetes mellitus or complications associated with type 1 or type 2diabetes mellitus include an insulin, e.g., human insulin, or a humaninsulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1analogues or GLP-1 receptor agonists, or an analogue or derivativethereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or apharmaceutically acceptable salt or solvate thereof, or any mixturethereof. As used herein, the terms “analogue” and “derivative” refers toa polypeptide which has a molecular structure which formally can bederived from the structure of a naturally occurring peptide, for examplethat of human insulin, by deleting and/or exchanging at least one aminoacid residue occurring in the naturally occurring peptide and/or byadding at least one amino acid residue. The added and/or exchanged aminoacid residue can either be codable amino acid residues or othernaturally occurring residues or purely synthetic amino acid residues.Insulin analogues are also referred to as “insulin receptor ligands”. Inparticular, the term “derivative” refers to a polypeptide which has amolecular structure which formally can be derived from the structure ofa naturally occurring peptide, for example that of human insulin, inwhich one or more organic substituent (e.g. a fatty acid) is bound toone or more of the amino acids. Optionally, one or more amino acidsoccurring in the naturally occurring peptide may have been deletedand/or replaced by other amino acids, including non-codeable aminoacids, or amino acids, including non-codeable, have been added to thenaturally occurring peptide.

Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) humaninsulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulinglulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28)human insulin (insulin aspart); human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin. Examples of insulin derivatives are, for example,B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®);B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin;B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 humaninsulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-gamma-glutamyl)-des(B30) humaninsulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30)human insulin (insulin degludec, Tresiba®);B29-N—(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, forexample, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®,Bydureon®, a 39 amino acid peptide which is produced by the salivaryglands of the Gila monster), Liraglutide (Victoza®), Semaglutide,Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®),rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide/HM-11260C, CM-3,GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen,Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701,MAR709, ZP-2929, ZP-3022, TT-401, BHM-034. MOD-6030, CAM-2036, DA-15864,ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten.

An example of an oligonucleotide is, for example: mipomersen sodium(Kynamro®), a cholesterol-reducing antisense therapeutic for thetreatment of familial hypercholesterolemia.

Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin,Saxagliptin, Berberine.

Examples of hormones include hypophysis hormones or hypothalamushormones or regulatory active peptides and their antagonists, such asGonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin),Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

Examples of polysaccharides include a glucosaminoglycane, a hyaluronicacid, a heparin, a low molecular weight heparin or an ultra-lowmolecular weight heparin or a derivative thereof, or a sulphatedpolysaccharide, e.g. a poly-sulphated form of the above-mentionedpolysaccharides, and/or a pharmaceutically acceptable salt thereof. Anexample of a pharmaceutically acceptable salt of a poly-sulphated lowmolecular weight heparin is enoxaparin sodium. An example of ahyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodiumhyaluronate.

The term “antibody”, as used herein, refers to an immunoglobulinmolecule or an antigen-binding portion thereof. Examples ofantigen-binding portions of immunoglobulin molecules include F(ab) andF(ab′)2 fragments, which retain the ability to bind antigen. Theantibody can be polyclonal, monoclonal, recombinant, chimeric,de-immunized or humanized, fully human, non-human, (e.g., murine), orsingle chain antibody. In some embodiments, the antibody has effectorfunction and can fix complement. In some embodiments, the antibody hasreduced or no ability to bind an Fc receptor. For example, the antibodycan be an isotype or subtype, an antibody fragment or mutant, which doesnot support binding to an Fc receptor, e.g., it has a mutagenized ordeleted Fc receptor binding region. The term antibody also includes anantigen-binding molecule based on tetravalent bispecific tandemimmunoglobulins (TBTI) and/or a dual variable region antibody-likebinding protein having cross-over binding region orientation (CODV).

The terms “fragment” or “antibody fragment” refer to a polypeptidederived from an antibody polypeptide molecule (e.g., an antibody heavyand/or light chain polypeptide) that does not comprise a full-lengthantibody polypeptide, but that still comprises at least a portion of afull-length antibody polypeptide that is capable of binding to anantigen. Antibody fragments can comprise a cleaved portion of a fulllength antibody polypeptide, although the term is not limited to suchcleaved fragments. Antibody fragments that are useful in the presentdisclosure include, for example, Fab fragments, F(ab′)2 fragments, scFv(single-chain Fv) fragments, linear antibodies, monospecific ormultispecific antibody fragments such as bispecific, trispecific,tetraspecific and multispecific antibodies (e.g., diabodies, triabodies,tetrabodies), monovalent or multivalent antibody fragments such asbivalent, trivalent, tetravalent and multivalent antibodies, minibodies,chelating recombinant antibodies, tribodies or bibodies, intrabodies,nanobodies, small modular immunopharmaceuticals (SMIP), binding-domainimmunoglobulin fusion proteins, camelized antibodies, and VHH containingantibodies. Additional examples of antigen-binding antibody fragmentsare known in the art.

The terms “Complementarity-determining region” or “CDR” refer to shortpolypeptide sequences within the variable region of both heavy and lightchain polypeptides that are primarily responsible for mediating specificantigen recognition. The term 35 “framework region” refers to amino acidsequences within the variable region of both heavy and light chainpolypeptides that are not CDR sequences, and are primarily responsiblefor maintaining correct positioning of the CDR sequences to permitantigen binding. Although the framework regions themselves typically donot directly participate in antigen binding, as is known in the art,certain residues within the framework regions of certain antibodies candirectly participate in antigen binding or can affect the ability of oneor more amino acids in CDRs to interact with antigen. Examples ofantibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g.,Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

Pharmaceutically acceptable salts of any API described herein are alsocontemplated for use in a drug or medicament in a drug delivery device.Pharmaceutically acceptable salts are for example acid addition saltsand basic salts.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the APIs, formulations,apparatuses, methods, systems and embodiments described herein may bemade without departing from the full scope and spirit of the presentdisclosure, which encompass such modifications and any and allequivalents thereof.

1-15. (canceled)
 16. A device for communicating a driving ability levelof a user, the device comprising at least a processor, a memory and awireless transceiver, wherein the device is configured to: receive,using the transceiver, a communication from a medical device, whereinthe communication comprises information relating to a condition of themedical device; and send, using the transceiver, a communication to avehicle; process, using the processor, the information relating to thecondition of the medical device in order to determine the drivingability level of the user based on an assignment of a category selectedfrom a group consisting of a first category and a second category. 17.The device according to claim 16, wherein the device is a smart keyassociated with the vehicle and configured to store a medical monitoringapplication.
 18. The device according to claim 16, wherein the device isconfigured to send the communication to a navigation system when thedriving ability level of the user is assigned to the second category.19. The device according to claim 16, wherein the device is configuredto send the communication to the vehicle via a smart key associated withthe vehicle.
 20. The device according to claim 16, wherein the device isconfigured to: store in the memory information relating to a medicationdose history of the user; determine, based on the stored medication dosehistory, a due time for a subsequent medication dose administration; andwirelessly transmit data representing the due time for the subsequentmedication dose administration to a smart key associated with thevehicle or to an electronic warning system of the vehicle.
 21. Thedevice according to claim 20, wherein the device is further configuredto: wirelessly communicate with an injection monitoring device toreceive dosing information from the injection monitoring device, thedosing information comprising a date, time and data representing anadministered medicament dose, wherein the device is further configuredto update the stored medication dose history based on the receiveddosing information.
 22. The device according to claim 21, wherein thedevice is further configured to determine a driving ability level of theuser by inferring a physiological condition of the user based on acomparison of a current time with the due time for the subsequentmedication dose administration.
 23. The device according to claim 21,wherein the device is configured to wirelessly transmit the datarepresenting the due time for the subsequent medication doseadministration to the electronic warning system of the vehicle.
 24. Thedevice according to claim 23, wherein the device is further configuredto perform a plausibility check in response to receiving the datarepresenting the due time for the subsequent medication doseadministration, the plausibility check comprising confirming thereceived dosing information.
 25. The device according to claim 23,wherein the device is configured to wirelessly transmit an indication ofa driving ability level of the user to the electronic warning system ofthe associated vehicle.
 26. The device according to claim 25, whereinthe device is further configured to perform a plausibility check inresponse to receiving the data representing the due time for thesubsequent medication dose administration, the plausibility checkcomprising confirming the received information.
 27. The device accordingto claim 25, wherein the smart key is further configured to: transmit anunlock signal to the associated vehicle; in response to transmitting theunlock signal to the associated vehicle, compare a current time with thereceived data representing the due time for the subsequent medicationdose administration; and communicate a result of the comparison to theelectronic warning system of the associated vehicle.
 28. The deviceaccording to claim 20, wherein the device is configured to wirelesslytransmit the data representing the due time for the subsequentmedication dose administration to the smart key associated with thevehicle, and the smart key is configured to: transmit an unlock signalto the vehicle; in response to transmitting the unlock signal to thevehicle, compare a current time with the received data representing thedue time for the subsequent medication dose administration; andcommunicate a result of the comparison to the electronic warning systemof the vehicle.
 29. The device according to claim 16, wherein themedical device is a permanent monitoring device and the communicationcomprises information relating to a physiological condition of a user.30. A system comprising: a device for communicating a driving abilitylevel of a user, the device comprising at least a processor, a memoryand a wireless transceiver, wherein the device is configured to:receive, using the transceiver, a communication from a medical device,wherein the medical device is a permanent monitoring device and thecommunication comprises information relating to a physiologicalcondition of the user; send a communication to a vehicle; wherein theinformation relating to the physiological condition of the user isprocessed in order to determine a driving ability level of the userbased on an assignment of a category selected from a group consisting ofa first category, a second category, and a third category; an electronicwarning system of the vehicle, wherein the electronic warning system ofthe vehicle is configured to emit a warning signal when the drivingability level of the user is assigned to the second category.
 31. Thesystem of claim 30, wherein the electronic warning system is configuredto prevent a starting of an engine of the vehicle or activate a safetyassistant system when the driving ability level of the user is assignedto the third category.
 32. The system of claim 30, wherein thecommunication comprises information relating to a condition of themedical device and the driving ability level of the user is based on theinformation relating to a condition of the medical device.
 33. Thesystem of claim 30, wherein the electronic warning system is configuredto not emit a warning signal when the driving ability level of the useris assigned to the first category.
 34. The system of claim 30, whereinthe electronic warning system is configured to: receive a result of thecomparison of a current time with a due time for the subsequentmedication dose administration; and emit a warning signal when thecurrent time is later than the due time.
 35. The system of claim 34,wherein the electronic warning system of the vehicle is furtherconfigured to prevent a starting of an engine of the vehicle when thecurrent time is later than the due time.